Acknowledgements. Expert Panel. Medication Safety Support Service (MSSS) Advisory Group. Why Anticoagulant Safety? Anticoagulation Principles

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1 Ontario Medication Safety Support Service Anticoagulant Project Co-leads: Acknowledgements Carmine Stumpo, Toronto East General Hospital Kris Wichman, ISMP Canada Donna Walsh, ISMP Canada Funded by the Ontario Ministry of Health and Long-Term Care Test Sites: Royal Victoria Hospital, Barrie Sunnybrook Health Sciences Centre, Toronto Toronto East General Hospital, Toronto York Central Hospital, Richmond Hill Swasti Bhajan Mathur, Rouge Valley Health System, Ajax/Pickering Judy Chong, Royal Victoria Hospital, Barrie Patti Cornish, Sunnybrook Health Sciences Centre, Toronto Nancy Giovinazzo, Joseph Brant Memorial Hospital, Burlington James Lam, Providence Health Care, Toronto Ming Lee, York Central Hospital, Richmond Hill Michelle Methot, Kingston General Hospital, Kingston Expert Panel Allan Mills, Trillium Health Centre, Toronto West/Mississauga Greg Soon, Peterborough Regional Health Centre, Peterborough Carmine Stumpo, Toronto East General Hospital, Toronto Marita Tonkin, Hamilton Health Sciences Centre, Hamilton Donna Walsh, ISMP Canada Kris Wichman, ISMP Canada David U, ISMP Canada Medication Safety Support Service (MSSS) Advisory Group Canadian Society of Hospital Pharmacists - Ontario Branch College of Nurses of Ontario College of Physicians and Surgeons of Ontario Institute for Safe Medication Practices Canada Ontario College of Pharmacists Ontario Hospital Association Ontario Medical Association Ontario Ministry of Health and Long-Term Care Ontario Pharmacists Association Registered Nurses Association of Ontario Why Anticoagulant Safety? Anticoagulation Principles Need to anticoagulate.. Need to anticoagulate SAFELY.. 1

2 Addressing Anticoagulation Safety Addressing Anticoagulant Safety Enhance venous thromboembolism (VTE) prophylaxis Errors of omission Enhance VTE prophylaxis: Project underway with Dr. Bill Geerts to improve the use of clinical practice guidelines. Enhance storage and administration of heparin Errors of commission Addressing Anticoagulant Safety Enhance storage and administration of heparin. Case #1: Heparin Storage A Patient Safety Priority Patient with a triple lumen central venous access device Received heparin flush in each lumen 3 times daily Post op day 5, aptt greater than 180 seconds; no other anticoagulant prescribed Outcome: intracerebral hemorrhage resulting in death ISMP Canada Safety Bulletin, Vol 6, Issue 10, December 30, 2006 Heparin Storage A Patient Safety Priority Heparin Storage A Patient Safety Priority Case #2: Neonatal ward in US hospital Heparin 10,000 units / ml stocked in dispensing cabinet instead of 10 units / ml vial Products look similar Nurses flushed with incorrect product Outcome 3 premature infants died ISMP Safety Alert, September 21,

3 Heparin Storage A Patient Safety Priority Questions: Is there a problem? Why are there so many choices? What is the current state of heparin storage in Ontario? What is contributing to the current usage patterns? How can we improve storage? Heparin Product Concentrations Available in Canada (ampoules and vials only) Heparin-Related Products Low Molecular Weight Heparins (LMWH) Enoxaparin (Lovenox ) Dalteparin (Fragmin ) Tinzaparin (Innohep ) Nadroparin (Fraxiparine ) Fondaparinux (Arixtra ) ISMP Canada Safety Bulletin, Vol 4, Issue 10, October, 2004 Use Heparin Flushes VTE prophylaxis VTE treatment Heparin IV Heparin Uses Route Heparin SC or LMWH SC (E.g., Dalteparin, Tinzaparin) Heparin IV bolus plus infusion LMWH SC (E.g, Dalteparin, Tinzaparin) Common Dosage Heparin 1,000 units in 10 ml Heparin 5,000 units SC or LMWH 2,500 to 5,000 units SC Heparin 5,000 units IV followed by 1,000 units per hour (approx) LMWH 15,000 units SC (approx) Heparin Uses Heparin Flushes units Limited evidence Routine use not recommended Acute Coronary Syndromes Heparin IV bolus plus infusion LMWH SC Fondaparinux SC Heparin 5,000 units IV followed by 1,000 units per hour (approx) Enoxaparin 1 mg / kg Fondaparinux 2.5 mg SC 3

4 Heparin Error Potential Number of products X Number of concentrations X Number of uses / formats / doses Canadian Hospital Survey 29 question survey sent to 856 healthcare facilities across Canada Addressing a variety of anticoagulant topics including heparin storage Response: 195 responses nation-wide Representing 38,350 hospital beds 97 Ontario respondents (Ontario) Utilization of Heparin 1,000 units / 10 ml (100 units/ml) ICU 38.9% OR 29.5% Emergency 49.5% Unit Cardiology Dialysis 8.4% 17.9% Surgery Medicine 41.1% 46.3% Pharmacy 75.8% 0.0% 10.0% 20.0% 30.0% 40.0% 50.0% 60.0% 70.0% 80.0% Percent (Ontario) Utilization of Heparin 10,000 units / 10 ml (1,000 units/ml) (Ontario) Utilization of Heparin 10,000 units / 1 ml ICU 29.5% ICU 21.1% OR 31.6% OR 22.1% Emergency 31.6% Emergency 27.4% Unit Cardiology Dialysis 14.7% 11.6% Unit Cardiology Dialysis 5.3% 9.5% Surgery 17.9% Surgery 17.9% Medicine 14.7% Medicine 22.1% Pharmacy 42.1% Pharmacy 44.2% 0.0% 5.0% 10.0% 15.0% 20.0% 25.0% 30.0% 35.0% 40.0% 45.0% Percent 0.0% 5.0% 10.0% 15.0% 20.0% 25.0% 30.0% 35.0% 40.0% 45.0% 50.0% Percent 4

5 (Ontario) Utilization of Heparin 50,000 units / 5 ml (10,000 units/ml) ICU OR Emergency 34.7% 38.9% 38.9% Units Cardiology Dialysis 16.8% 23.2% Surgery 31.6% Medicine 44.2% Pharmacy 65.3% 0.0% 10.0% 20.0% 30.0% 40.0% 50.0% 60.0% 70.0% Percent Summary: High dose / concentration products prevalent Stocked with lower dose products (flushes) Few interventions made Intervention The Goals: Appropriate use of heparin Before addressing heparin storage, must first address usage Safety strategies to minimize selection errors Project Development Coordination by ISMP Canada Expert advisory panel formed Process developed to achieve goals Identification / creation of tools to facilitate Analysis Product choices Information sharing Resource kit developed 5

6 Learning from Project Development one size does not fit all Need to use a systematic approach to identify and address areas of risk Recommendations - Overview 1. Assess heparin storage throughout hospital. 2. Address appropriate use of heparin. 3. Reduce the number of potential high-risk situations related to heparin storage. Recommendation 1: Heparin Audit Systematic Process for Heparin Review: Review products and quantities stored throughout the hospital; Assess intended use for each heparin product stored; Identify and remove unnecessary products; and Identify appropriate quantities to be stored. Audit and Assessment Tool Step by step approach Documentation (pre and post) Impact analysis Cost Analysis Cost Analysis Estimated annual costs for VTE prophylaxis: Heparin Format Cost* Heparin 5,000 unit pre-filled syringe (Healthmark) Heparin 5,000 / 0.2 ml amp Heparin 10,000 units / 1 ml vial Heparin 50,000 units / 2 ml vial Heparin 50,000 units / 5 ml vial Heparin 500 unit pre-filled syringe (Healthmark) Heparin 1,000 units / 10 ml $2.00 $1.29 $1.34 $0.92 $0.38 $0.87 $1.90 Heparin Format Heparin 5,000 unit pre-filled syringe (Healthmark) Heparin 5,000 / 0.2 ml amp Heparin 10,000 units / 1 ml vial Heparin 50,000 units / 2 ml vial Heparin 50,000 units / 5 ml vial Cost* $93,659 $60,410 $62,752 $43,083 $17,795 *Based on average contract prices for a single dose *Assuming average VTE prophylaxis rates in a 400 bed acute care facility 6

7 LMWH Storage Available as both multidose vials and pre-filled syringes Multidose vials present a safety hazard May be more concentrated Large quantity of drug per vial No cost differential for pre-filled syringes Barrier to use: need for pre-approved dose ranges Recommendation 2: Appropriate Use Assess current use and compare with best practice: Review use of unfractionated heparin to ensure alignment with the evidence based guidelines (e.g., ACCP) Considerations: VTE prophylaxis re evidence-based guidelines Increase use Flushing / locking of access lines Decrease use of heparin where possible Consider LMWH use Recommendation 3: Reduce Potential High-Risk Situations A/ In patient care areas: Remove formats of high dose heparin products from stock in patient care areas: 50,000 units/5 ml 50,000 units/2 ml Review and reduce, where possible, availability of the following products in patient care areas: 10,000 units/1 ml 10,000 units/10 ml Recommendation 3: Reduce Potential High-Risk Situations Simplify and standardize heparin product selection: i. Define protocols and standardize products for IV and SC use and for heparin flushes. ii. Select optimal product formats. For example: For continuous IV infusions, select one standardized concentration and purchase pre-mixed solutions. For SC administration, use single dose formats such as 5,000 unit pre-filled syringes or ampoules. If using heparin to flush a central venous access device, use appropriate concentrations (e.g., 10 units/ml, 100 units/ml). iii. When SC, IV and heparin flush doses must be stocked in the same area, maximize differentiation using segregation, labelling, product format and other techniques. Recommendation 3: Reduce Potential High-Risk Situations B/In Pharmacy: Review storage areas to ensure adequate safeguards to prevent selection errors. Heparin Safety Strategies Experience Pilot Site: York Central Hospital Ming Lee 7

8 Implementation Implementation General Strategies Motion was approved by Pharmacy, Nutrition & Therapeutics Committee and Safe Medication Practice Committee to remove high dose heparin products from stock hospital wide Review of products, indications and pre-printed orders Education of all staff and physicians Work with all physician and nursing groups to change stock and pre-printed orders Minimize stock of heparin products with individual patient specific prescriptions where possible York Central Hospital Experience Removal of 50,000u/5mL vials hospital wide Limited stock in limited areas consolidated to 1000u heparin (i.e. OR, PACU, DI, ICU) and 100u/mL (i.e. ICU, DI, PACU) 10,000u/mL provided as patient specific unit dose prescription in acute care areas Pre-printed orders reviewed and many revised (e.g. Heparin infusion protocol use premixed heparin 25,000u/500mL D5W solution) Move to use of LMWH for orthopedic DVT prophylaxis and preprinted orders approved by the Surgical Program Use of sodium citrate for renal patients Implementation Implementation York Central Hospital Experience Successes Increased awareness of high dose heparin risks hospital wide Collaboration and support of all practitioners physicians, nurses, pharmacists and pharmacy technicians Adoption of revised pre-printed orders with significant practice impact (i.e. use of LMWH and premixed heparin) Independent double check for heparin infusions and subcutaneous injections Participation in the Canadian Thromboprophylaxis Patient Safety Initiative (CTPSI) helped in providing education to all physician groups, nurses and pharmacists York Central Hospital Experience Challenges Time for consultation process (i.e. pre-printed orders, etc) Storage space on units Decision to use commercially available pre-filled syringe or wait for IV admixture service (redevelopment required) Implementation York Central Hospital Experience Next Steps Continue to revise pre-printed orders Continue to consolidate stock to one of the approved products Decision on 5000u heparin format Questions? 8

9 Questions? 9